VISTOGARD Drug Patent Profile
✉ Email this page to a colleague
When do Vistogard patents expire, and what generic alternatives are available?
Vistogard is a drug marketed by Wellstat Therap and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and seventy-five patent family members in twenty-one countries.
The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.
DrugPatentWatch® Generic Entry Outlook for Vistogard
Vistogard was eligible for patent challenges on September 4, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 10, 2023. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VISTOGARD
| International Patents: | 175 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 67 |
| Patent Applications: | 267 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in VISTOGARD? | VISTOGARD excipients list |
| DailyMed Link: | VISTOGARD at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for VISTOGARD
Generic Entry Date for VISTOGARD*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for VISTOGARD
| Ingredient-type | Analogs/Derivatives Pyrimidines |
| Drug Class | Pyrimidine Analog |
Anatomical Therapeutic Chemical (ATC) Classes for VISTOGARD
US Patents and Regulatory Information for VISTOGARD
VISTOGARD is protected by two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VISTOGARD is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting VISTOGARD
Acylated uridine and cytidine and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: EMERGENCY TREATMENT OF ADULT & PEDIATRIC PATIENTS FOLLOWING FLUOROURACIL OR CAPECITABINE OVERDOSE,OR WHO EXHIBIT EARLY-ONSET,SEVERE OR LIFE-THREATENING CARDIAC OR CNS TOXICITY OR UNUSUALLY SEVERE ADVERSE REACTIONS WITHIN 96 HOURS
FDA Regulatory Exclusivity protecting VISTOGARD
EMERGENCY TX OF PTS FOLLOWING A FU OR CAPECITABINE OD, OR WHO EXHIBIT EARLY-ONSET, SEVERE OR LIFE-THREATENING TOXICITY AFFECTING THE CARDIAC SYSTEM OR CNS, AND/OR EARLY-ONSET, UNUSUALLY SEVERE AR W/IN 96 HRS FOLLOWING THE END OF FU OR CAPECITABINE ADMIN.
Exclusivity Expiration: See Plans and Pricing
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VISTOGARD
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VISTOGARD
See the table below for patents covering VISTOGARD around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 667676 | See Plans and Pricing | |
| Canada | 2504078 | NUCLEOSIDES PYRIMIDINE ACYLES UTILISES POUR TRAITER LA TOXICITE DES AGENTS CHIMIOTHERAPEUTIQUES ET ANTIVIRAUX (TREATMENT OF CHEMOTHERAPEUTIC AGENT AND ANTIVIRAL AGENT TOXICITY WITH ACYLATED PYRIMIDINE NUCLEOSIDES) | See Plans and Pricing |
| Denmark | 176007 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VISTOGARD
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1849470 | SPC/GB17/049 | United Kingdom | See Plans and Pricing | PRODUCT NAME: TRIFLURIDINE WITH TIPACRIL HYDROCHLORIDE; REGISTERED: UK EU/1/16/1096/001(NI) 20160427; UK EU/1/16/1096/002(NI) 20160427; UK EU/1/16/1096/003(NI) 20160427; UK EU/1/16/1096/004(NI) 20160427; UK EU/1/16/1096/005(NI) 20160427; UK EU/1/16/1096/006(NI) 20160427; UK PLGB 05815/0112 20160427; UK PLGB 05815/0113 20160427 |
| 1849470 | 2017C/028 | Belgium | See Plans and Pricing | PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427 |
| 1849470 | LUC00036 | Luxembourg | See Plans and Pricing | PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2022 - 2023
NCE-1 Patent Challenge Dates 2022 - 2023
ClinicalTrialExchange - Connecting volunteers and trials
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com.
Follow DrugPatentWatch:
